NuvOx Pharma ensured the continuation of Phase 2 clinical trial of its NanO2 in Covid-19 patients with acute hypoxic respiratory failure, as it got No Objection Letter from Health Canada.
In an email to Pharmaceutical Daily, NuvOx explained that the trial has not started yet, but Health Canada has allowed the company to start it.
NuvOx said in the email the trial will enroll up to 129 patients who have abnormally low oxygen saturation, in the early stages of respiratory failure due to covid-1. Those are patients who have an oxygen saturation less than 90% when breathing room air, or less than 92% when breathing 6L/minute of pure oxygen, but who are not yet mechanically ventilated.
NuvOx said in the email “We know from unrelated trials like the RECOVERY trial that patients in the early stages of respiratory failure still have high mortality rates in the range of 21.5%-25%. We do not have specific historical survival data in similar patient populations, but we can get an estimate from the large scale RECOVERY trial in 2,104 patients where the 28 day mortality rate of patients requiring supplemental oxygen without mechanical ventilation was 21.5% in those receiving dexamethasone vs 25% with the standard of care.”
TUCSON, Ariz.–(BUSINESS WIRE)–NuvOx Pharma, a Tucson-based biotechnology company developing NanO2™ emulsion for oxygen delivery, has received a “No Objection Letter” from Health Canada to proceed with a Phase IIa clinical trial of NanO2 in COVID-19 subjects with acute hypoxic respiratory failure (AHRF). Some patients with AHRF can progress to a more severe form of the disease called acute respiratory distress syndrome (ARDS). ARDS, which is associated with lung inflammation leading to low blood oxygenation, is the major cause of death in COVID-19 patients.
Evan Unger, MD, President and CEO of NuvOx Pharma, said: “We had data in several animal models showing that NanO2 restored oxygen levels in conditions of low oxygen caused by ARDS or acute lung injury. We already have data in humans from when NanO2 was tested in subjects with brain cancer and stroke showing safety and evidence of efficacy in both indications. Because of this, we designed a clinical trial to study NanO2 in COVID-19 patients.”
Diego Martin, MD, PhD, Chairman of Radiology at McGill University, Montreal, Canada, Principal Investigator of the Canadian efforts on the trial, said: “We are excited to collaborate with NuvOx Pharma on this project. I have been collaborating with Dr. Unger to study models of myocardial infarction where we have published evidence that shows NanO2 can act as a cardioprotectant. In addition to ARDS, COVID-19 patients suffer multi-organ damage to the heart, brain, kidneys and other organs. In fact, a large percentage of patients who succumb to COVID-19 also have underlying cardiac disease or cardiovascular risk factors. NanO2 appears to be reversing ischemia-mediated pathways of inflammation and tissue injury in lung, heart and other tissues, which may make it particularly well-suited as a treatment in COVID-19 subjects.”
Jarrod Mosier, a Principal Investigator of the US sites in the clinical trial. Dr. Mosier said: “NanO2 will be administered as a sustained IV infusion in the clinical trial. The first phase of the trial is a dose escalation design to determine the best dose, after which additional subjects will be enrolled at that dose as a dose expansion phase. The trial will determine if NanO2 improves clinical outcomes in COVID-19 subjects with acute hypoxic respiratory failure. NanO2 has the potential to transform the care of COVID-19 patients who present with low oxygen saturation.”